- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188002
A Web-based Tailored Health Behavior Intervention for Breast and Colon Cancer Survivors (eWellness) (eWellness)
December 3, 2019 updated by: University of North Carolina, Chapel Hill
The primary objective of this study is to compare the differences in fruits and vegetable intake and physical activity from pre- to post- study between the intervention and control groups (i.e. the difference in differences).
The study involves the use of web-based educational materials over a four week period.
The investigators hypothesize that those in the intervention group will show a greater increase in fruit and vegetable intake and engage in more physical activity than those randomized to the control group.
Eligible breast and colorectal cancer survivors from the UNC Health Registry/Cancer Survivorship Cohort (UNC HR/CSC) will be selected, consented, and randomized to either the intervention or control group.
Both groups will fill out baseline surveys.
The intervention group will receive a total to 4 newsletters for 4 weeks and at the beginning of week 5, they will asked to complete the follow-up survey online.
The intervention newsletters focus on increasing physical activity and healthy diets.
The control group will receive 4 newsletters in the same time frame as the intervention.
The focus of the control group's newsletters will be on topics relevant to cancer survivors (e.g.
getting back to work after treatment, managing finances) but will not focus on physical activity or diet.
All contact with participants will take place online (i.e.
surveys and newsletter delivery) from the study web site.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is adapted from the WATCH (Wellness for African Americans Through Churches) Project.
WATCH was a randomized trial among 587 African American members of 12 rural North Carolina churches that demonstrated the effectiveness of a mailed tailored print and video intervention consisting of four individually tailored newsletters and targeted videos to improve diet and physical activity behaviors: there were significant improvements in fruit and vegetable consumption (0.6 servings) and recreational physical activity (2.5 MET-hours per week), and a non-significant decrease in fat intake in the intervention churches.
The overall goal of this application is to conduct a study (called "eWellness") to investigate whether the WATCH tailored print messages and videos can be effectively and efficiently disseminated to a different population (breast and colon cancer survivors) and using a different delivery channel (electronic technology via the internet and world wide web.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥18 years of age
- primary language is English
- histologically confirmed stage 1-111A invasive breast cancer or stage 1-3 colorectal cancer
- between at least 6 months to 5 years since completion of all primary cancer treatments (e.g. surgery, radiation, chemotherapy with the exception of women on adjuvant Herceptin therapy)
- have access to the internet; have an email and/or cell phone (to accept text message reminders from the study).
Exclusion criteria:
Include women that may be pregnant and anyone that is/has:
- A history of another cancer (exception for non-melanoma skin cancers)
- Self-reported comorbidities that would preclude engaging in physical activity safely (e.g. functional limitations or symptomatic cardiovascular or pulmonary disease)
- Plans or scheduled for major surgery (including breast reconstruction) during the intervention time frame
- Any psychiatric illness that would make it difficult to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control - Fruit and Vegetable
Participants in this arm will receive usual care.
|
4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g.
returning to work)
|
Other: Physical Activity Intervention
Participants in this arm will be encouraged via tailored newsletters and email/or text reminders to improve diet and physical activities.
|
4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Fruit and Vegetable Score
Time Frame: Month 6
|
Fruit and vegetable consumption will be adapted from a 35-item measure used in a trial for US Blacks adapted from a 35-item measure for US Southern blacks that measures frequency of intake during the previous month.
Score measures can range from 2-24.
Positive or better outcomes are reflected by higher mean fruit and vegetable scores.
|
Month 6
|
Summary Fruit and Vegetable Score
Time Frame: Month 6
|
The frequency of fruit and vegetable intake will be measured during the previous month, using a 2-item measure (How many servings of fruits do you eat each day?) and a similar question for vegetables that assesses usual vegetable intake.
Scores can range from 0-N with higher scores indicating more fruit and/or vegetable intake.
|
Month 6
|
Metabolic Equivalent Task Hours (METs) for Physical Activity
Time Frame: Month 6
|
Moderate to physical activity will be assessed and frequency of different types of activity, with response options of: don't do, 1-3 times/month, 1-2 times/week, 3-4 times/week, or 5 or more times/week.
Items include various types of activities gathered from an 11-item instrument modified for cultural appropriateness from a previous study.
For each activity, participants estimate duration as either <20 minutes or 20 or more minutes per session.
Physical activity is then calculated in terms of metabolic equivalent task hours (METs) per week.
MET values for energy expenditure were assigned to each activity based on validated instruments.21
MET-hours are computed by multiplying frequency times duration (converted to hours/week) times the MET value.
Reported physical activity time can range from 0 minutes - 6 hours or more for reported sedentary behaviors.
Higher reported values equate to better reported outcomes of increased physical activity for participants.
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: Month 6
|
Recruitment rate is defined as the number of screened participants that meet eligibility criteria divided by the number of individuals screened.
|
Month 6
|
Percentage of Participants Completing the Intervention and Follow-Up Assessments
Time Frame: Month 6
|
Retention
|
Month 6
|
Number of Newsletters Read/Downloaded
Time Frame: Month 6
|
Participant Adherence
|
Month 6
|
Program Process Evaluation
Time Frame: 6 months
|
This will be assessed with process evaluation questions at follow-up survey and metrics of website use (e.g.
number of times visiting site).
Questions will ask about participants' perceptions and experiences with the intervention and may provide valuable information about how to modify the programs for future use in this population.
Measures will be adapted from those used in our previous studies and assess ease of use, intervention instructions and length, attractiveness, perceived personal relevance, recall, credibility, novelty, and usefulness for making healthy changes, and satisfaction with intervention components.
Higher values will represent better outcomes for program process evaluation.
|
6 months
|
Number of Times Visiting the Site
Time Frame: 6 months
|
An evaluation of website metrics will be conducted to assess program acceptability.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Carmina Valle, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2017
Primary Completion (Actual)
July 31, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
December 3, 2019
First Submitted That Met QC Criteria
December 3, 2019
First Posted (Actual)
December 5, 2019
Study Record Updates
Last Update Posted (Actual)
December 5, 2019
Last Update Submitted That Met QC Criteria
December 3, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-1897
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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